Commission Implementing Regulation (EU) 2023/2703 of 4 December 2023 granting a Union authorisation for the single biocidal product EuLA oxi-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2023-12-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, biocide, chemical product, decontamination, market approval, oxide








L_202302703EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2703


5.12.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2703
of 4 December 2023
         
granting a Union authorisation for the single biocidal product ‘EuLA oxi-lime 23’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 29 March 2018, European Lime Association aisbl submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a single biocidal product named ‘EuLA oxi-lime 23’ of product-types 2 and 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-VJ038509-19 in the Register for Biocidal Products.












(2)


‘EuLA oxi-lime 23’ contains calcium oxide (burnt lime) as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 3.












(3)


On 13 December 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘EuLA oxi-lime 23’ and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘EuLA oxi-lime 23’ is a biocidal product within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.












(6)


On 18 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘EuLA oxi-lime 23’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0028963-0000 is hereby granted to European Lime Association aisbl for the making available on the market and use of the biocidal product ‘EuLA oxi-lime 23’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 25 December 2023 to 30 November 2033.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 December 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 14 June 2022 on the Union authorisation of ‘EULA OXI-LIME 23’ (ECHA/BPC/342/2022), https://echa.europa.eu/it/opinions-on-union-authorisation




ANNEX
Summary of product characteristics for a biocidal product

EuLA oxi-lime 23


Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)


Product type 3 - Veterinary hygiene (Disinfectants)


Authorisation number: EU-0028963-0000


R4BP asset number: EU-0028963-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product







Trade name(s)


EuLA oxi-lime 23




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


European Lime Association aisbl




Address


c/o IMA-Europe aisbl, Rue des Deux Eglises 26 box 2 , B-1000 Brussels Belgium




Authorisation number


EU-0028963-0000





R4BP asset number



EU-0028963-0000




Date of the authorisation


25 December 2023




Expiry date of the authorisation


30 November 2033




1.3.   Manufacturer(s) of the product







Name of manufacturer


Cal Industrial SL




Address of manufacturer


Pedro I, 19-21 31 007 Pamplona Spain




Location of manufacturing sites


Pedro I, 19-21 31 007 Pamplona Spain













Name of manufacturer


Calera de Alzo, S. L.




Address of manufacturer


Postal number: 20.268, Egileor auzoa, 101. Altzo (Guipúzcoa), 20.268 Altzo (Guipúzcoa) Spain




Location of manufacturing sites


Egileor auzoa, 101. Altzo, 20.268 Altzo (Guipúzcoa) Spain













Name of manufacturer


Caleras de San Cucao, S.A.




Address of manufacturer


Agüera s/n 33425, - San Cucao de Llanera Spain




Location of manufacturing sites


Agüera s/n 33425, - San Cucao de Llanera Spain













Name of manufacturer


Cales Pascual S.L.




Address of manufacturer


C/ Cura Bau, 15, 46112 Valencia Spain




Location of manufacturing sites


Ctra. Valencia-Ademuz, KM 9.3. Paterna, KM 9.3 Valencia Spain













Name of manufacturer


CalGov




Address of manufacturer


Carretera Fuente, Apartado 2, 41 560 Estepa Spain




Location of manufacturing sites


Carretera Fuente, Apartado 2, 41 560 Estepa Spain













Name of manufacturer


Carmeuse Chaux




Address of manufacturer


215 route d’Arras, 62320 Bois Bernard France




Location of manufacturing sites


215 route d’Arras, 62320 Bois Bernard France













Name of manufacturer


Carmeuse Czech Republic s.r.o.




Address of manufacturer


Mokrá 359, Mokrá, 664 04 Mokrá, Czech Republic




Location of manufacturing sites


závod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá, Czech Republic













Name of manufacturer


Carmeuse Holding Srl




Address of manufacturer


Str.Carierei Nr.127A, 500047 Brasov Romania




Location of manufacturing sites







Str Garii 2, 135100 Fieni Romania




Str Principala 1, 337457 Com. Soimus Romania




Valea Mare Privat, 117805 Campulung Romania

















Name of manufacturer


Carmeuse Hungaria kft




Address of manufacturer


HRSZ 064/1, 7827 Beremend Hungary




Location of manufacturing sites


HRSZ 064/1, 7827 Beremend Hungary













Name of manufacturer


Carmeuse SA




Address of manufacturer


Rue du Château 13a, 5300 Seilles Belgium




Location of manufacturing sites







Rue de Boudjesse 1, 5070 Aisemont Belgium




Rue du Val Notre Dame 300, 4520 Moha Belgium




Rue du Château 13a, 5300 Seilles Belgium

















Name of manufacturer


Carmeuse Slovakia s.r.o.




Address of manufacturer


-, 04911 Slavec Slovakia




Location of manufacturing sites







závod Vápenka Košice, Vstupný areál U.S. Steel, 04454 Košice Slovakia




závod Vápenka Slavec, Slavec 179, 049 11 Slavec Slovakia

















Name of manufacturer


Carrières et Chaux Balthazard et Cotte




Address of manufacturer


Rue du Pra Paris, 38360 Sassenage France




Location of manufacturing sites


Rue du Pra Paris, 38 360 Sassenage France













Name of manufacturer


Carrières et fours à chaux de Dugny




Address of manufacturer


B.P.1, 55 100 Dugny-sur-Meuse France




Location of manufacturing sites


B.P.1, 55 100 Dugny-sur-Meuse France













Name of manufacturer


Cementos Tudela Veguín, S.A.U.




Address of manufacturer


CL Argüelles 25, 33003 Oviedo Asturias Spain




Location of manufacturing sites


CL Tino Casal, s/n., 33910 Tudela Veguín, Asturias Spain













Name of manufacturer


Chaux de Boran




Address of manufacturer


Route de Boran, 60 640 Précy-Sur-Oise France




Location of manufacturing sites


Route de Boran, 60 640 Précy-Sur-Oise France













Name of manufacturer


Chaux de Bretagne




Address of manufacturer


-, 53600 Evron France




Location of manufacturing sites


-, 53600 Evron France













Name of manufacturer


Chaux de Provence




Address of manufacturer


Ancien Chemin de Martigues, 13 160 Châteauneuf Les Martigues France




Location of manufacturing sites


Ancien Chemin de Martigues, 13 160 Châteauneuf Les Martigues France













Name of manufacturer


Chaux et Dolomies du Boulonnais




Address of manufacturer


Rue Jules Guesde, 62 720 Réty France




Location of manufacturing sites


Rue Jules Guesde, 62 720 Réty France













Name of manufacturer


Chaux de la Tour




Address of manufacturer


1 chemin des Chaux de la Tour, 13 820 Ensues La Redonne France




Location of manufacturing sites


1 chemin des Chaux de la Tour, 13 820 Ensues La Redonne France













Name of manufacturer


Clogrennane Lime LTD




Address of manufacturer


Clogrennane Lime LTD, Clogrennane, R93 EV26 Carlow Ireland




Location of manufacturing sites


Clogrennane, R93 EV26, Ireland Carlow Ireland













Name of manufacturer


Dumont-Wautier




Address of manufacturer


Rue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse Belgium




Location of manufacturing sites


Rue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse Belgium













Name of manufacturer


Etablissement Leon Lhoist




Address of manufacturer


Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium




Location of manufacturing sites


Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium













Name of manufacturer


Européenne des Chaux et Liants




Address of manufacturer


2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu France




Location of manufacturing sites


Usine de Duin, 38460 TREPT France













Name of manufacturer


Lhoist Bukowa Sp. z o.o.




Address of manufacturer


Bukowa, ul. Osiedlowa 10, 29-105 Krasocin Poland




Location of manufacturing sites


Bukowa, ul. Osiedlowa 10, 29-105 Krasocin Poland













Name of manufacturer


Lhoist Central Europe / Lhoist Česká republika a Slovensko Vápenka Čertovy schody a.s




Address of manufacturer


Tmaň 200, 267 21 Tmaň Czech Republic




Location of manufacturing sites


Tmaň 200, 267 21 Tmaň Czech Republic













Name of manufacturer


Lhoist Faxe Kalk A/S




Address of manufacturer


Hovedgaden 13, 4654 Faxe Ladeplads Denmark




Location of manufacturing sites







Nordkajen 17, 7100 Vejle Denmark




Gl. Strandvej 14, 4640 Faxe Denmark

















Name of manufacturer


Lhoist France Ouest




Address of manufacturer


15 rue Henri Dagallier, 38 100 Grenoble France




Location of manufacturing sites


15 rue Henri Dagallier, 38 100 Grenoble France













Name of manufacturer


Lhoist UK Ltd




Address of manufacturer


Hindlow, Buxton, SK17 OEL Derbyshire United Kingdom




Location of manufacturing sites


Hindlow, Buxton, Derbyshire, SK17 OEL Derbyshire United Kingdom













Name of manufacturer


Lusical




Address of manufacturer


Valverde, 2025-201 Alcanede Portugal




Location of manufacturing sites


Valverde, 2025-201 Alcanede Portugal













Name of manufacturer


Nordkalk AB




Address of manufacturer


Box 901, SE-731 29 Köping Sweden




Location of manufacturing sites







Nordkalk AB, Köping, Kungsängsvägen 22, SE-731 36 Köping Sweden




Nordkalk AB, KPAB Storugns Lärbro, Lärbro Storugns 2741, SE-624 53 Lärbro Sweden

















Name of manufacturer


Nordkalk AS




Address of manufacturer


Faehlmanni tee 11A, Rakke, 46 301 Lääne-Virumaa Estonia




Location of manufacturing sites


Faehlmanni tee 11A, Rakke, 46 301 Lääne-Virumaa Estonia













Name of manufacturer


Nordkalk Oy Ab




Address of manufacturer


Skräbbölevägen 18, 21600 Pargas Finland




Location of manufacturing sites







Nordkalk Oy Ab, Louhi, Louhi, Fi-57100 Savonlinna Finland




Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, Fi-08100 Lohja Finland




Nordkalk Oy Ab, Pargas, Kalkhamnsvägen 5, 21600 Pargas Finland

















Name of manufacturer


Pigeon Chaux SAS




Address of manufacturer


29 Rue des Ruettes, 53410 Saint-Pierre-la-Cour France




Location of manufacturing sites


La Hunaudiere, 53480 Vaiges France













Name of manufacturer


See Bruyeres & Fils




Address of manufacturer


Le Bourg, 47500 Saint Front sur Lémance France




Location of manufacturing sites


Le Bourg, 47500 Saint Front sur Lémance France













Name of manufacturer


Singleton Birch




Address of manufacturer


Melton Ross Quarries, Barnetby, DN38 6AE N Lincolnshire United Kingdom




Location of manufacturing sites


Melton Ross Quarries, Barnetby, DN38 6AE N Lincolnshire United Kingdom













Name of manufacturer


SMA Mineral AB




Address of manufacturer


Box 329, SE-682 27 Filipstad Sweden




Location of manufacturing sites







Luleå lime plant, C/O SSAB Europe, SE-971 88 Luleå Sweden




Boda lime plant, Kärvsåsen Kalkveerksvägen 15, SE-795 96 Boda kyrkby Sweden




Rättivik lime plant, Kalkvägen 7, SE-795 32 RÄTTVIK Sweden




SSAB Industriområde, Kalkverket, SE-613 80 Oxelösund Sweden

















Name of manufacturer


SMA Mineral Burgas Var LTD




Address of manufacturer


dis. Pobeda, Chataldzha str. No52, 8002 Burgas Bulgaria




Location of manufacturing sites


dis. Pobeda, Chataldzha str. No52, 8002 Burgas Bulgaria













Name of manufacturer


SMA Mineral Oy




Address of manufacturer


Selleenkatu 281, 95450 Torino Finland




Location of manufacturing sites


Röyttä Lime Plant Selleenkatu 281, 95450 Torino Finland













Name of manufacturer


Société des fours à chaux de Sorcy




Address of manufacturer


Route de Sorcy, B.P.16, 55 190 Void France




Location of manufacturing sites


Route de Sorcy, B.P.16, 55 190 Void France













Name of manufacturer


Spenner GmbH & Co. KG




Address of manufacturer


Bahnhofstraße 20, D-59597 Erwitte Germany




Location of manufacturing sites


Hüchtchenweg 2, D-59597 Erwitte Germany













Name of manufacturer


Tarmac, Lime and Powders




Address of manufacturer


Tunstead House, Wormhill, Buxton, SK17 8TG Derbyshire United Kingdom




Location of manufacturing sites







Tunstead Quarry, Wormhill, Buxton, SK17 8TG Derbyshire United Kingdom




Hindlow Works, Sterndale Moor, Buxton, SK17 9QD Derbyshire United Kingdom

















Name of manufacturer


Trzuskawica S.A.




Address of manufacturer


Sitkówka 24, 26-052 Nowiny Poland




Location of manufacturing sites


Trzuskawica S.A., Sitkówka 24, 26-052 Nowiny Poland













Name of manufacturer


Unicalce S.p.A




Address of manufacturer


Via Tonio da Belledo, 30, l-23900 Lecco (LC), Italy




Location of manufacturing sites







Via Ponti, 18, 1-24012 Val Brembilla (BG) Italy




Via Lisso 12, I-24010 Sedrina (BG) Italy




Strada Amerina Località S.Pellegrino, l-05035 Narni (TR) Italy




Via Di S.Vincenzo 21, I-57021 Campiglia Marittima (LI) Italy




S.S.Appia km 134, l-04020 Itri (LT) Italy




S.S.Appia km 134, l-04020 Itri (LT) Italy




Contrada Lupini – C.P.33, l-74019 Palagiano (TA) Italy

















Name of manufacturer


Vápenka Vitošov s.r.o




Address of manufacturer


č.p. 54, 78901 Hrabová Czech Republic




Location of manufacturing sites


č.p. 54, 78901 Hrabová Czech Republic













Name of manufacturer


Wietersdorfer & Peggauer Zementwerke GmbH




Address of manufacturer


Wietersdorf 1, 9373 Klein St. Paul Austria




Location of manufacturing sites


Alois-Kern-Straße 1, 8120 Peggau Austria













Name of manufacturer


Zakłady Wapiennicze Lhoist S.A.




Address of manufacturer


ul. Wapiennicza 7, 46-050 Tarnów Opolski Poland




Location of manufacturing sites







ul. Fabryczna 22, 47-316 Górażdże Poland




ul. Wapiennicza 7, 46-050 Tarnów Opolski Poland




ul. Wapiennicza 7, 46-050 Tarnów Opolski Poland




ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów Poland

















Name of manufacturer


Zement- und Kalkwerke Otterbein GmbH & Co. KG




Address of manufacturer


Hauptstrasse 50, 36137 Grossenlueder-Mues Germany




Location of manufacturing sites


Georg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues Germany













Name of manufacturer


SMA Mineral AS




Address of manufacturer


Postbox 500, NO-8601 Mo I Rana Norway




Location of manufacturing sites


Mo Industripark, Verkstedsøypa, NO-8626 Mo I Rana Norway




1.4.   Manufacturer(s) of the active substance(s)







Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Cal Industrial SL




Address of manufacturer


Pedro I, 19-21, 31 007 Pamplona, Spain




Location of manufacturing sites


Pedro I, 19-21, 31 007 Pamplona Spain













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Calera de Alzo, S. L.




Address of manufacturer


Egileor auzoa, 101, 20.268 Altzo (Guipúzcoa) Spain




Location of manufacturing sites


Egileor auzoa, 101, 20.268 Altzo (Guipúzcoa) Spain













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Caleras de San Cucao, S.A.




Address of manufacturer


Agüera s/n, 33425 San Cucao de Llanera, Spain




Location of manufacturing sites


Agüera s/n, 33425 San Cucao de Llanera, Spain













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


CalGov




Address of manufacturer


Carretera Fuente, Apartado 2, 41 560, Estepa Spain




Location of manufacturing sites


Carretera Fuente, Apartado 2, 41 560, Estepa, Spain













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carmeuse Chaux




Address of manufacturer


215 route d’Arras, 62320 Bois Bernard France




Location of manufacturing sites


215 route d’Arras, 62320 Bois Bernard France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carmeuse Czech Republic s.r.o.




Address of manufacturer


závod Vápenka Mokrá, Mokrá 359,, 664 04 Mokrá Czech Republic




Location of manufacturing sites


závod Vápenka Mokrá, Mokrá 359,, 664 04 Mokrá Czech Republic













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carmeuse Holding Srl




Address of manufacturer


Str.Carierei Nr.127A,, 500047 Brasov Romania




Location of manufacturing sites







Str Garii 2,, 135100 Fieni Romania




Str Principala 1,, 337457 Com. Soimus Romania




Valea Mare Pravat,, 117805 Campulung Romania

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carmeuse Hungaria kft




Address of manufacturer


HRSZ 064/1,, 7827 Beremend Hungary




Location of manufacturing sites


HRSZ 064/1,, 7827 Beremend Hungary













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carmeuse SA




Address of manufacturer


Rue du Château 13a,, 5300 Seilles Belgium




Location of manufacturing sites







Rue de Boudjesse 1,, 5070 Aisemont Belgium




Rue du Val Notre Dame 300,, 4520 Moha Belgium




Rue du Château 13a,, 5300 Seilles, Belgium

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carmeuse Slovakia s.r.o




Address of manufacturer


závod Vápenka Slavec 179,, 04911 Slavec Slovakia




Location of manufacturing sites







závod Vápenka Slavec 179,, 04911 Slavec Slovakia




závod Vápenka Košice, Vstupný areál U.S. Steel, 0455 Košice Slovakia

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carrières et Chaux Balthazard et Cotte




Address of manufacturer


Rue du Pra Paris, 38360 Sassenage, France




Location of manufacturing sites


Rue du Pra Paris, 38360 Sassenage France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Carrières et fours à chaux de Dugny




Address of manufacturer


B.P.1,, 55 100 Dugny-sur-Meuse France




Location of manufacturing sites


B.P.1,, 55 100 Dugny-sur-Meuse France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Cementos Tudela Veguín, S.A.U.




Address of manufacturer


CL Argüelles 25., 33003 Oviedo, Asturias Spain




Location of manufacturing sites


CL Tino Casal, s/n., 33910, Tudela Veguín, Asturias, Spain













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Chaux de Boran




Address of manufacturer


Route de Boran, 60640 Précy-Sur-Oise France




Location of manufacturing sites


Route de Boran, 60640 Précy-Sur-Oise France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Chaux de Provence




Address of manufacturer


Ancien Chemin de Martigues, 13160 Châteauneuf Les Martigues France




Location of manufacturing sites


Ancien Chemin de Martigues, 13160 Châteauneuf Les Martigues France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Chaux et Dolomies du Boulonnais




Address of manufacturer


Rue Jules Guesde,, 62 720 Réty France




Location of manufacturing sites


Rue Jules Guesde,, 62 720 Réty France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Chaux de la Tour




Address of manufacturer


1 chemin des Chaux de la Tour,, 13 820 Ensues La Redonne France




Location of manufacturing sites


1 chemin des Chaux de la Tour,, 13 820 Ensues La Redonne France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Clogrennane Lime LTD




Address of manufacturer


Clogrennane, R93 EV26 Carlow, Ireland




Location of manufacturing sites


Clogrennane, R93 EV26 Carlow, Ireland













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Dumont-Wautier




Address of manufacturer


Rue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse, Belgium




Location of manufacturing sites


Rue la Mallieue, 95,, B-4470 Saint-Georges-sur-Meuse, Belgium













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Etablissement Leon Lhoist




Address of manufacturer


Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium




Location of manufacturing sites


Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Européenne des Chaux et Liants




Address of manufacturer


2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu France




Location of manufacturing sites


Usine de Duin,, 38460 TREPT France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Lhoist Bukowa Sp. z o.o




Address of manufacturer


Bukowa, ul. Osiedlowa 10,, 29-105 Krasocin Poland




Location of manufacturing sites


Bukowa, ul. Osiedlowa 10,, 29-105 Krasocin Poland













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Lhoist France Ouest




Address of manufacturer


15 rue Henri Dagallier,, 38 100 Grenoble France




Location of manufacturing sites


15 rue Henri Dagallier,, 38 100 Grenoble France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Lusical




Address of manufacturer


Valverde, 2025-201 Alcanede Portugal




Location of manufacturing sites


Valverde, 2025-201 Alcanede Portugal













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Nordkalk AB




Address of manufacturer


Box 901, SE-731 29 Köping Sweden




Location of manufacturing sites







Kungsängsvägen 22, SE-731 36 Köping Sweden




Lärbro Storugns 2741, SE-624 53, Lärbro Sweden

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Nordkalk AS




Address of manufacturer


Faehlmanni tee 11A, Rakke, 46 301, Lääne-Virumaa Estonia




Location of manufacturing sites


Faehlmanni tee 11A, Rakke, 46 301, Lääne-Virumaa Estonia













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Nordkalk Oy Ab




Address of manufacturer


Skräbbölevägen 18, 21600 Pargas Finland




Location of manufacturing sites







Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, Fi-08100, Lohja Finland




Nordkalk Oy Ab, Pargas, Kalkhamnsvägen 5, Fi-21600, Pargas Finland




Nordkalk Oy Ab, Louhi, Louhi, Fi-57100 Savonlinna Finland

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Pigeon Chaux SAS




Address of manufacturer


29 Rue des Ruettes, 53410 Saint-Pierre-la-Cour France




Location of manufacturing sites


La Hunaudiere -, 53480 Vaiges France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


See Bruyeres & Fils




Address of manufacturer


Le Bourg -, 47500 Saint Front sur Lémance, France




Location of manufacturing sites


Le Bourg -, 47500 Saint Front sur Lémance, France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Singleton Birch




Address of manufacturer


Melton Ross Quarries, DN38 6AE Barnetby, , N Lincolnshire United Kingdom




Location of manufacturing sites


Melton Ross Quarries, DN38 6AE Barnetby, N Lincolnshire United Kingdom













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


SMA Mineral AB




Address of manufacturer


Box 329,, SE-682 27 Filipstad Sweden




Location of manufacturing sites







Luleå lime plant, C/O SSAB Europe, SE-971 88 Luleå Sweden




Boda lime plant, Kärvsåsen Kalkveerksvägen 15, SE-795 96 Boda kyrkby Sweden




Rättivik lime plant, Kalkvägen 7, SE-795 32 RÄTTVIK Sweden




SSAB Industriområde, Kalkverket,, SE-613 80 Oxelösund, Sweden

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


SMA Mineral Burgas Var LTD




Address of manufacturer


Chataldzha str. No52, 8002, Burgas, dis. Pobeda Bulgaria




Location of manufacturing sites


Chataldzha str. No52, 8002, Burgas, dis. Pobeda Bulgaria













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


SMA Mineral Oy




Address of manufacturer


Selleenkatu 281, 95450 Torino Finland




Location of manufacturing sites


Röyattä lime plant, Selleenkatu 281, 95450 Torino Finland













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Société des fours à chaux de Sorcy




Address of manufacturer


Route de Sorcy B.P.16, 55 190 Void France




Location of manufacturing sites


Route de Sorcy B.P.16, 55 190 Void France













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Spenner GmbH & Co. KG




Address of manufacturer


Bahnhofstraße 20, D-59597 Erwitte Germany




Location of manufacturing sites


Hüchtchenweg 2, D-59597 Erwitte Germany













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Trzuskawica S.A.




Address of manufacturer


Trzuskawica S.A., Sitkówka 24,, 26-052 Nowiny, Poland




Location of manufacturing sites


Trzuskawica S.A., Sitkówka 24,, 26-052 Nowiny, Poland













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Unicalce S.p.A




Address of manufacturer


Via Tonio da Belledo, 30, l-23900 Lecco (LC), Italy




Location of manufacturing sites







Via Ponti, 18, 1-24012 Val Brembilla (BG), Italy




Via Lisso, 12, l-24010 Sedrina (BG) Italy




Strada Amerina Località S.Pellegrino, l-05035 Narni (TR) Italy




Via Di S.Vincenzo 21, I-57021 Campiglia Marittima (LI) Italy




S.S.Appia km 134, l-04020 Itri (LT) Italy




Contrada Lupini – C.P.33, l-74019 Palagiano (TA) Italy

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Vápenka Vitošov s.r.o.




Address of manufacturer


č.p. 54, 78901 Hrabová, Czech Republic




Location of manufacturing sites


č.p. 54, 78901 Hrabová, Czech Republic













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Wietersdorfer & Peggauer Zementwerke GmbH




Address of manufacturer


Wietersdorf 1, 9373 Klein St. Paul, Austria




Location of manufacturing sites


Alois-Kern-Straße 1, 8120 Peggau Austria













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Zakłady Wapiennicze Lhoist S.A.




Address of manufacturer


ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland




Location of manufacturing sites







ul. Fabryczna 22, 47-316 Górażdże Poland




ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland




ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów Poland

















Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Zement- und Kalkwerke Otterbein GmbH & Co. KG




Address of manufacturer


Hauptstrasse 50, 36137 Grossenlueder-Mues Germany




Location of manufacturing sites


Georg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues Germany













Active substance


Calcium oxide/lime/burnt lime/quicklime




Name of manufacturer


Lhoist UK Ltd




Address of manufacturer


Hindlow, Buxton, SK17 OEL Derbyshire United Kingdom




Location of manufacturing sites


Hindlow, Buxton, SK17 OEL Derbyshire United Kingdom




2.   PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Calcium oxide/lime/burnt lime/quicklime


 


Active Substance


1305-78-8


215-138-9


100,0




2.2.   Type of formulation

DP - Dustable powder
3.   HAZARD AND PRECAUTIONARY STATEMENTS







Hazard statements


Causes skin irritation.
Causes serious eye damage.
May cause respiratory irritation.
Reacts violently with water.




Precautionary statements


Avoid breathing dust.
Wash hands thoroughly after handling.
Use only outdoors or in a well-ventilated area.
Wear protective gloves, protective clothing, eye protection and face protection.
IF ON SKIN:Wash with plenty of water.
Specific treatment (see instructions on this label).
If skin irritation occurs:Get medical advice.
Take off contaminated clothing.And wash it before reuse.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTRE or doctor/physician.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
Call a poison center/doctor if you feel unwell.
Store in a well-ventilated place.Keep container tightly closed.
Dispose of container in accordance with local regulations.
Store locked up.




4.   AUTHORISED USE(S)

4.1.   Use description


Table 1.


Use # 1 – Disinfection of sewage sludge







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: -
Scientific name: Endoparasites
Common name: Helminth eggs
Development stage: -




Field(s) of use


Indoor




Application method(s)


Method: automatic direct application
Detailed description:
The product is dosed into the sewage sludge and mixed by means of a blender. The dry product is mixed by means of a blender. The dry product is mixed with the sewage sludge in an open mixer.
The product should be loaded by fully automated processes.




Application rate(s) and frequency


Application Rate: 0,15 - 1,5 kg product / kg dry weight of substance; typical dry solid content - 12-25 % in sewage sludge
Dilution (%): - Ready to use (RTU) product
Number and timing of application:

The application rate must be sufficient to maintain a pH of > 12 and a temperature >50°C during the contact time.

Contact time: 24 hours




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with Polypropylene (PP) or Polyethylene (PE) inner layer): 500 - 1 200  kg




4.1.1.   Use-specific instructions for use







—


The dose must be sufficient to maintain a pH of > 12 and a temperature >50°C during the 24 hour contact time.










—


Application rate : 0,15 – 1,5 kg product / kg dry weight of substrate; typical dry solids content - 12-25% in sewage sludge.










—


The ratio may vary between application and treatment plant designs. The user must ensure that the treatment is effective through preliminary laboratory test that guarantee efficacy according to the legislation applicable to each case.




4.1.2.   Use-specific risk mitigation measures







—


The loading of the product into the treatment unit and the application must be done fully automatically.










—


The loading into the treatment unit and the disposal of empty big bags or sacks (500 - 1 200 kg) must be performed using a telehandler (including a closed cabin).










—


During the loading of the product and the disposal of empty bags or sacks, wear:






—


a respiratory protective equipment (RPE) at least assigned protection factor (APF) 40 (airtight face piece covering eyes, nose, mouth and chin according to European Standard (EN) 149 with a P3 filter or equivalent);










—


chemical resistant gloves EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


During the treatment of sewage sludge, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in absence of collective management measures to estimate and prevent an exposure greater than the EU occupational exposure limit value (OEL) of 14 mg/m3 for that gas.










—


During the manual handling of treated sewage sludge wear protective gloves in accordance with EN 374 or equivalent and protection coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the sewage sludge.










—


The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See section 6 for the full titles of the EN standards and legislation.










—


The cleaning of the treatment unit must be avoided or performed with an automated process with no exposure of the professional.




4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

-
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

-
4.2.   Use description


Table 2.


Use # 2 – Disinfection of manure







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: -
Scientific name: Viruses
Common name: Viruses
Development stage: -
Scientific name: Endoparasites
Common name: Helminth eggs
Development stage: -




Field(s) of use


Indoor




Application method(s)


Method: Automatic direct application
Detailed description:
The product is mixed with the manure. The product is dosed into the manure and mixed by means of a blender.
The product shall be loaded by fully automated processes.




Application rate(s) and frequency


Application Rate: -
Dilution (%): - RTU product
Number and timing of application:
The application rate must be sufficient to maintain a pH of > 12 and a temperature > 60°C during the contact time.
Contact time: 24 hours




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with PP or PE inner layer): 500 - 1 200  kg




4.2.1.   Use-specific instructions for use







—


The application rate must be sufficient to maintain a pH of > 12 and a temperature > 60°C during the 24 hour contact time.










—


Do not apply more than 100 kg product /m3 of manure.










—


The mixture should be moistened and any self-ignition that might occur should be extinguished with water.










—


After the necessary contact time, remove the treated manure from the animal house. Use of the treated manure according to local legislation.




4.2.2.   Use-specific risk mitigation measures







—


The loading of the product into the treatment unit and the application must be done fully automatically.










—


The loading into the treatment unit and the disposal of empty bags or sacks must be performed using a telehandler (including a closed cabin).










—


During the loading of the product and the disposal of empty bags or sacks, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalant);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 or equivalant (coverall material to be specified by the authorisation holder within the product information).














—


During the treatment of the manure, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU OEL of 14 mg/m3 for that gas.










—


During the manual handling of treated manure wear protective gloves in accordance with EN 374 or equivalent and protection coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the manure.










—


The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See section 6 for the full titles of the EN standards and legislations.










—


The cleaning of the treatment unit must be avoided or performed with an automated process with no exposure of the professional.










—


Do not apply the product if releases from animal housings or manure/slurry storage areas can be directed to a sewage treatment plant or directly to surface water.




4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

-
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

-
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

-
4.3.   Use description


Table 3.


Use # 3 – Disinfection of indoor floor surfaces of animal accommodations and transportation







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: -
Scientific name: Yeast
Common name: Yeasts
Development stage: -
Scientific name: Fungi
Common name: Fungi
Development stage: -
Scientific name: viruses
Common name: Viruses
Development stage: -




Field(s) of use


Indoor




Application method(s)


Method: Direct application
Detailed description:
The product is spread directly onto the floors of animal accomodations using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.




Application rate(s) and frequency


Application Rate: 800 g product / m2

Dilution (%): - RTU product
Number and timing of application:
Frequency in animal housing: before each production cycle.
Frequency in animal transportation: after each animal transport.
Contact time: 48 hours




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with PP or PE inner layer): 500 - 1 200  kg
Paper sacks (with PP or PE inner layer): 25 kg




4.3.1.   Use-specific instructions for use







—


The product is spread onto the floors of animal accommodations and transportation using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.










—


A long-handled shovel must be used for the manual spreading application.










A.


On concrete floors:






1.


Wash the surface with running water;










2.


Sprinkle approximatively 800 g of product / m2 to cover the damp ground and add 0,9 litre/m2 of water;










3.


Leave to act for at least 48 hours.














B.


On beaten-earth floor:






1.


Brush and wet the surface;










2.


Sprinkle approx. 800 g of product / m2 on the damp ground and add 0,9 litre/m2 of water;










3.


Leave to act for at least 48 hours.








4.3.2.   Use-specific risk mitigation measures







—


During the loading, the application of the product and the disposal of empty bags or sacks, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


For the use of big bags or sacks (500-1 200 kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin).










—


During the loading of small sacks (25 kg), thoroughly empty out the sacks in order to minimise the remaining powder.










—


Fold carefully the small bag in order to avoid any spills.










—


During the disposal of any residues of the product after the application, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See section 6 for the full titles of the EN standards and legislation.










—


Animals must not be present during the entire treatment duration.










—


Remove residues of the product on the ground by sweeping before re-entry of animals.










—


Feed and drinking water must be carefully covered or removed during the application of the product.










—


Do not apply the product if releases from animal housings, manure/slurry storage areas or animal transportation disinfection areas can be directed to a sewage treatment plant or directly to surface water.




4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

-
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging







—


After treatment, remove the product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements.
For animal transportation use only: after brushing, rinse and clean the vehicle.




4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

-
4.4.   Use description


Table 4.


Use # 4 – Disinfection of floors of outdoor animal enclosures







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: -
Scientific name: Yeast
Common name: Yeasts
Development stage: -
Scientific name: other fungi
Common name: Fungi
Development stage: -
Scientific name: Virus
Common name: Virus
Development stage: -




Field(s) of use


Outdoor




Application method(s)


Method: Direct application
Detailed description:
The product is spread directly onto the surfaces (floors) of animal enclosures using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.




Application rate(s) and frequency


Application Rate: 600 - 800 g product/m2

Dilution (%): - RTU product
Number and timing of application:
Contact time 48 hours
Frequency: maximum two applications per year.




Category(ies) of users


Professional




Pack sizes and packaging material


Bulk powder
Big bags or sacks (with PP or PE inner layer): 500 - 1 200  kg
Paper sacks (with PP or PE inner layer): 25 kg




4.4.1.   Use-specific instructions for use

Before the introduction of new animals:






—


Brush and wet the floor.










—


spread 600 - 800 g product/m2 onto the ground then add 0,9 litre/m2 of water.










—


leave to act for at least 48 hours.
Do not apply in the case of wind or rain.




4.4.2.   Use-specific risk mitigation measures







—


During the loading, the application of the product on the floor and the disposal of empty bags, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


For the use of big bags or sacks (500-1 200 kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin).










—


During the loading of small sacks (25 kg), thoroughly empty out the sacks to minimise the remaining powder.










—


Fold carefully the small bag in order to avoid any spills.










—


During the disposal of the product after the application, wear:






—


RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to NF EN 149 with a P3 filter or equivalent);










—


chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);










—


protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).














—


The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.










—


See section 6 for the full titles of the EN standards and legislation.










—


Do not exceed two applications per year.










—


Animals must not be present during the entire treatment duration.










—


Remove the residues of the product on the ground by thorough sweeping before allowing re-entry of animals.










—


Feed and drinking water must be carefully covered or removed during the application of the product.




4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

-
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging







—


After treatment, remove the product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements.




4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

-
5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use







—


Comply with the instructions for use.










—


Respect the conditions of use of the product.










—


Refer to hygiene plan in place in order to ensure that necessary efficacy level is achieved.










—


For outdoor uses, do not apply in the case of rain or wind




5.2.   Risk mitigation measures







—


Do not let bystanders (including co-workers and children) and pets enter the treatment area during the entire treatment duration (including the loading, the application of the product, the disposal of empty bags or sacks, the required contact time and the subsequent removal of the product and its residues from the ground).










—


Use only in a well-ventilated area.




5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment







—


IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.










—


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.










—


IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTER or a doctor.










—


IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid or propionic acid.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) or down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage







—


Do not store at a temperature above 30°C.










—


Protect from humidity.










—


Shelf-life: 15 months.




6.   OTHER INFORMATION

Full titles of EN standards and legislation referred to in sections 4.1.2 - 4.4.2:






 


EN 149 - Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking;










 


EN 374 - EN ISO 374-1: 2018: Protective gloves against dangerous chemicals and micro-organisms. Part 1: terminology and performance requirements for chemical risks;










 


EN 13982 - Protective clothing for use against solid particulates - Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates;










 


EN 14387 - EN 14387:2021: Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking;










 


EN 14126 - BS EN 14126: 2003 - Protective clothing. Performance requirements and tests methods for protective clothing against infective agent;










 


Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11.






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.



ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj
ISSN 1977-0677 (electronic edition)